Supervisor, Manufacturing

Catalent•Harmans, MD

6d•$110,000 - $130,000•Onsite

About The Position

The Supervisor, Manufacturing will lead teams executing upstream manufacturing and support-area procedures using standard operating procedures and batch records. The role oversees upstream production equipment and processes, including process monitoring, media preparation, and harvesting, and ensures personnel are trained and compliant before entering the production floor while maintaining quality and safety standards. This position supervises day-to-day manufacturing operations, personnel, and production activities to ensure safe, efficient, and compliant execution. It leads and develops teams in GMP requirements, safety, and operational excellence; manages employee performance and talent initiatives; and ensures production batches meet quality, regulatory, and GMP requirements, including batch review and closeout with Quality Assurance. The supervisor also maintains manufacturing documentation, leads deviation investigations and CAPA activities, collaborates across functions to execute production campaigns and technology transfers, oversees critical processes and equipment, and drives continuous improvement. The role is based at Catalent’s Harmans/BWI site in Maryland and is 100% onsite. The stated schedule is a 7 p.m.–7 a.m. shift on a 2-2-3 rotation.

Requirements

Master’s degree in a Scientific, Engineering, or Biotech field and 4–6 years of experience in upstream biologic production processes under GMP compliance; or a bachelor’s degree in one of those fields and 6–8 years of such experience; or a high school diploma or associate degree and 8–10 years of such experience.
Experience in mammalian or microbial cell culture.
Solid experience with large-scale centrifuges, washers, and autoclaves.
Ability to apply scientific and technical knowledge to solve routine production challenges, operate equipment effectively, and support manufacturing operations.
Ability to maintain accurate GMP documentation, including batch records, SOPs, deviations, summary reports, and related manufacturing records.
Strong communication, collaboration, and teamwork skills, including the ability to work with technical and non-technical stakeholders.
Continuous learning, adaptability, creativity, and multitasking abilities, with commitment to professional growth and process improvement.

Nice To Haves

Experience with bacterial fermentation processes in a GMP environment, including bioreactor setup and operation, aseptic processing, process monitoring, sampling, troubleshooting, and batch record documentation.
Demonstrable leadership experience at Catalent, including participation in programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW, may be considered in place of external experience.

Responsibilities

Supervise day-to-day manufacturing operations, personnel, and production activities to ensure safe, efficient, and compliant execution.
Lead, train, coach, and develop teams in GMP requirements, safety standards, and operational excellence.
Foster collaboration, accountability, diversity, and continuous development to build high-performing, engaged teams.
Manage employee performance through coaching, performance reviews, hiring support, onboarding, and talent-retention initiatives.
Ensure production batches meet quality, regulatory, and GMP requirements, including batch review and closeout with Quality Assurance.
Author, review, and maintain SOPs, batch records, logbooks, validation protocols, and related manufacturing records.
Lead deviation investigations, CAPA activities, and compliance initiatives to drive quality improvements and regulatory readiness.
Partner with QA, MS&T, Engineering, Facilities, Project Management, and clients to execute production campaigns and technology transfers.
Oversee critical manufacturing processes, equipment operation, maintenance coordination, validation activities, and scientific data analysis.
Drive continuous improvement by identifying process efficiencies, resolving operational challenges, and providing regular production updates to stakeholders.
Ensure team members are fully trained and compliant before entering the production floor.
Perform other duties as assigned.